Association of shared decision-making with financial toxicity and coping actions in adult patients with cancer: a nationwide study in China

Abstract Objective Evidence on the impact of shared decision-making (SDM) on the financial toxicity (FT) of patients with cancer in real clinical settings is lacking. Using a nationwide patient survey in China, we aimed to identify the prevalence of SDM, FT as well as its consequent coping actions, and investigate their associations in adult patients with cancer. Methods A cross-sectional survey was administered to patients with cancer near discharge at 33 tertiary public cancer hospitals across China between January and March 2021. The FT was measured using the COST (comprehensive score for financial toxicity) tool and was categorized into 3 groups: no (COST 26-44), mild (COST 14-25), and moderate or severe (COST 0-13) FT. SDM was measured using 2 items from patient’s perspective. The surveyed questionnaire also included patient’s coping actions, demographics, and clinical information. Multinomial logistic regression was used to investigate the association between SDM and FT, and for sensitivity analysis, linear regression was also used taking the COST score as a dependent variable. Pearson’s chi-square tests were used for association analyses of coping actions with FT and SDM. Results A total of 5008 adult patients with cancer were included, of which 26.18%, 54.13%, and 19.69% patients were categorized as no FT, mild FT, and moderate or severe FT with the average COST score of 21.0 for all patients. Besides, 3943 (78.73%) patients reported a better SDM. Better SDM had significantly lower odds of developing high FT than worse SDM (adjusted ORmild vs no 0.50, 95% CI 0.39-0.56; adjusted ORmoderate or severe vs no 0.63, 95% CI 0.50-0.80). In sensitivity analysis, better SDM was significantly associated with higher COST scores (β: 1.34, 95% CI 0.85-1.83), which indicated lower FT. Patients with higher FT were more likely to take adverse coping actions including treatment nonadherence, limiting basic health service expense, reducing leisure activity expense, and loan. Conclusions Adult patients with cancer reporting worse SDM tended to experience higher FT and those with higher FT tended to take adverse coping actions. Understanding the impact of SDM on FT is crucial to inform early interventions designed to mitigate FT and consequent coping actions in cancer care practice.


Background
Cancer is the leading cause of death worldwide and in China.Nearly 19.3 million new cancer cases and 10.0 million cancer deaths occurred globally in 2020, of which 24% new cases and 27% deaths occurred in China. 1 Early diagnosis and appropriate treatment are effective in increasing survival and prolonging life for patients with cancer, while heavy financial burden limited accessibility and utilization of appropriate care for patients with cancer. 2 A rapid rise in health care costs and high out-of-pocket spending for patients with cancer is occurring due to innovative medication and therapy in China. 3A multicenter retrospective survey conducted in China found total expenditures for health services of patients with colorectal cancer increased e1032 ][17][18] Solutions and mitigation strategies need urgent focus in order to address FT in cancer care.
Shared decision-making (SDM), a kind of potential intervention strategy that oncologists and health systems can take to mitigate FT. 19 It works by involving clinicians and patients, sharing the best available evidence and decision support, and recognizing the needs, values, and preferences of individuals and their families. 20,21The American Society of Clinical Oncology (ASCO) also has recommended clinicians take the costs of cancer care into treatment discussion. 22A recent review outlined 4 potential strategies to mitigate FT including FT screening, financial navigation and assistance, incorporating cost information into treatment decision-making, as well as minimizing low-value care, while it revealed deficient implementation of these interventions in clinical practice. 19Another review also found the effectiveness of intervention strategies in mitigating FT across diverse health care systems was little known. 23An empirical study among 95 patients with metastatic breast cancer found patient-driven and shared decision trended toward lower FT comparing physician-driven decision. 24However, evidence from large-scale clinical practice about the status of SDM and its impact on the FT of cancer care is lacking worldwide and in China.
This nationwide cross-sectional study aimed to describe the prevalence of SDM, FT as well as coping actions among adult patients with cancer in China, and investigate their associations.

Study design
The China National Patient Surveys, conducted annually between 2015 and 2021, were a part of evaluation program of the National Healthcare Improvement Initiative initiated by National Health Commission of the People's Republic of China.The details of surveys have been described in previous studies. 17,25,26This survey regarding cancer care was based on the fifth round of China National Patient Surveys in 2021.At least one public tertiary cancer hospital for each province, autonomous region, and municipality in China was recruited and finally, 33 tertiary public cancer hospitals were included, which covered nearly half of public cancer hospitals in China.These surveyed hospitals are all comprehensive cancer centers and represent the local prominent performance of cancer care.This study was approved by the Ethics Committee of the Institute of Medical Biology of Chinese Academy of Medical Sciences (IPB-2020-23).

Patients
At least 150 inpatients to be discharged within 1-2 days and willing to participate in this study were continuously recruited from each hospital between January and March 2021.Approximately 5%-10% of inpatients in each hospital refused participation in this study.The inpatients only to be discharged were recruited because they experienced the whole process of hospitalization service and were going to pay their medical expenses, thus they have more accurate and completed perceptions of SDM and FT.During the session of investigation, a total of 5417 inpatients were interviewed by trained investigators and all of them completed the electronic questionnaire.All patients provided informed consent for their participation in the study.This study mainly focused on adult patients with cancer, thus 336 patients diagnosed as noncancer and 18 patients under 18 years old were excluded from our study.Finally, 5008 (92.4%) patients were included in our analyses (Figure 1).

Patient information
Patient characteristics included patients' socio-demographics (gender, age, marital status, ethnicity, education, registered residency region, annual household income, household size, medical insurance, and medical assistance) and clinical The Oncologist, 2024, Vol. 29, No. 8 e1033 information (cancer type, cancer stage, years since diagnosis, self-reported health status, and length of hospital stay).

Financial toxicity
Financial toxicity was quantified using the COST tool, which included 12 items rated with the 5-point Likert scale.The total score of the COST ranged from 0 to 44 points.Lower scores indicated higher FT and worse financial conditions.We categorized FT into 3 groups based on a proposed grading scale by De Souza JA: no (COST 26-44), mild (COST 14-25), and moderate or severe (COST 0-13) FT. 27

Shared decision-making
In this study, SDM was assessed from patient's perspective using 2 items: (1) clinicians carefully explained to me about treatment schemes including pros and cons and (2) clinicians took my treatment preferences into account.These 2 items were from a part of cancer patient experience scale, 26 as an exploratory tool to measure the implemented status of SDM in clinical settings.They were designed based on the concept of SDM (clinicians should share the best available evidence and decision support, and recognize the needs, values, and preferences of patients and their families).Rounds of discussion and revisions were made by a panel of experts including oncologists, researchers, and statisticians.Each patient gave a score for every item according to their experience during this hospital stay, using a 5-point Likert scale (5-strongly agreed to 1-strongly disagreed).The correlation coefficient of 2 items was 0.63, with a sound internal consistency.SDM was classified into binary variable, defined as better SDM when the average score of 2 items was over 4, and worse SDM when the average score of 2 terms was 4 or below.

Coping actions
The coping actions were collected using a survey question, "have you ever taken the following actions due to financial difficulties," followed by 7 items with "yes" or "no" responses: 1. once considered quitting treatment, 2. have delayed treatment for more than 7 days, 3. have failed to take medicine as instructed, 4. did not conduct medical checks as instructed, 5. have reduced spending on leisure activities, such as shopping or travelling, 6. have reduced spending on basic health services, such as clinic visits or vaccinations, 7. have borrowed money from relatives and friends or acquired a loan from bank due to illness.

Statistical analysis
Descriptive statistics were used to summarize FT, SDM, coping actions, and characterize the patient population.Pearson's chi-square tests were used to explore associations of patient characteristics with SDM and FT, as well as for associations of various coping actions with SDM and FT.Multinomial logistic regression was used to identify the association between SDM and FT with patient characteristics as covariates.Ordered logistic regression was not used because the parallel assumption was not accepted.For sensitivity analysis, we also explored the adjusted association between SDM and FT using multivariate linear regression, taking the COST score as a dependent variable.All statistical analyses were conducted with Stata/SE 15.0 software (Stata Corp LP, College Station, TX, USA).A 2-tailed P-value of < .05 was considered statistically significant.

Financial toxicity
The average score of COST for all patients was 21.0 with a SD 9.  1).

Shared decision-making
Of 5008 patients, 3943 (78.73%) patients reported better SDM.Patients with higher education level, urban registered residency, higher annual household income, UEBMI, advanced stage, and shorter years since diagnosis trended toward a higher possibility of having better SDM.Patients with stomach and colorectal cancer were more likely to report better SDM (Table 2).

Association between SDM and FT
Multinomial logistic regression was conducted to identify the association between SDM and FT.Compared with their counterparts, patients with better SDM were 50% less likely to have mild FT (adjusted OR 0.50, 95% CI 0.39-0.56),37% less likely to have moderate or severe FT (adjusted OR 0.63, 95% CI 0.50-0.80;Table 3).For sensitivity analysis, a multivariate linear regression with COST score as the dependent variable was conducted.All VIFs were below 10.The R 2 of the model was 0.1706, and the regression coefficient of SDM is 1.34 (95% CI 0.85-1.83;Table 4).That is, patients experiencing better SDM had an average 1.34 higher score of COST, which indicated lower FT.Besides, being male, being single/divorced/widowed, lower education level, rural registered residency, lower annual household income, bigger household size, receiving medical assistance, advanced or unknown cancer stage, longer years since diagnosis, worse self-reported health status, and shorter hospital stay were risk factors of FT; older age (between 65 and 90 years old) and with a diagnose of benign tumor were protective factors of FT (Supplementary Table S1).

Coping actions
Of 5008 patients, 12.14% of patients once considered quitting treatment, 5.31% delayed their treatment, 4.71% failed to take medicine as instructed, and 2.52% did not conduct medical checks as instructed.Besides, 35 reduced their leisure activity expense, 11.9% reduced their basic health service expense, and 19.77% borrowed money from relatives and friends or acquired a loan from a bank.Compared with patients without FT, patients with higher FT were more likely to take adverse coping actions (all P < .001; Figure 2).Compared with those with better SDM, patients with worse SDM were more likely to take some coping actions (P < .05)except reducing leisure activity expense and basic health service expense (Figure 3).

Discussion
This is a national cross-sectional study conducted in 2021, covering over 5000 patients with cancer in 33 public tertiary cancer hospitals across China.Among surveyed patients, over half of the patients had mild FT, and about one-fifth had moderate or severe FT, which indicated a high prevalence of FT among Chinese patients with cancer.From the patient's perspective, 78.73% of patients reported a good experience with SDM, including clinicians explaining treatment schemes to them and respecting their treatment preference.This study identified positive associations of better SDM and lower FT as well as coping actions and highlighted the importance of implementing SDM in the clinical practice of cancer care.This study also described patient characteristics of those reporting worse SDM and higher FT, which were useful for early screening and intervention among at-risk patients.

SDM level among Chinese patients with cancer
Patient engagement in decision-making has gradually become popular in clinical practice in recent years and substitutes the long-established physician-led decision-making in China, accompanied with the development of patientcentered value.However, related researches on SDM in China are badly deficient, and the first study on the clinical practice of SDM was in 2015. 28In our study, 78.7% of patients reported a good perception of SDM during their hospital stay.A study conducted at 16 hospitals in China in 2019-2020 identified that 73.8% of patients reported a good perceived decision participation among their cancer care, which is relatively consistent with our study although different patient-reported measures were used. 29A systematic review summarized various instruments of assessing the process of SDM during surgical consultations and found the results from patient-or clinician-reported measures were higher than those from observer-rated measures, in which patientor clinician-reported SDM rate of 54%-93% compared with observer-rated SDM of 7%-39%. 30A review also revealed that patient-perceived SDM showed association with patient outcomes than observer-rated SDM, and highlighted the importance of understanding the patient's perspective as critical to the science of measuring SDM. 31

Associations of SDM with FT and coping actions
This study confirmed significant associations of SDM with mitigating FT and adverse coping actions in the clinical practice of cancer care.The positive association may derive from multiple impact pathways.For one thing, through involving patients in treatment decision, clinicians tended to adjust medical schemes so as to balance curative effect and medical cost. 24,32For another thing, deep communication and considerable caring help in relieving patient's stress and worries.A study among 247 adolescent and young adult cancer survivors also found cost discussions were related to long-term FT. 33Overall, SDM has a crucial impact on the perceived burden and subsequent behavior changes of patients, our study enhances the evidence from patients with cancer in China.

Patient characteristics associated with SDM
5][36] This study preliminarily explored some patient-level risk factors on the implementation of SDM in clinical settings.Patients having lower socioeconomic status were less engaged in SDM, including those with rural registered residency, lower annual income, and lower education level, which is consistent with previous studies. 37Patients with better socioeconomic status tend to have higher health literacy, thus they could better understand clinical information and prefer to participate in decision-making and gain more decision support. 38Improving health literacy is a continuous health undertaking, but health care providers should consider to give more patience to these at-risk groups today.Besides, for patients with longer years since diagnosis and at the early cancer stage in our study, their SDM and decision support were overlooked in clinical practice.0][41] The need for SDM training program and cost information support was urged, and these should be considered in health system design.

Patient characteristics associated with FT
Finding characteristics of patients prone to FT is of great value for early screening and taking measures to mitigate FT and accompanying adverse coping actions.Male and middleaged patients tend to encounter greater financial difficulties because they are usually the main breadwinner of the family, and loss of productivity following cancer leads to a sharp drop in household income. 42The expensive medical cost often affects not only patients but also their entire family.Different family structures present contrasting ability to fight economic shock.Our studies found patients with nonmarried status or large household size perceived greater financial stress.Socioeconomic status is the most direct indicator for perceived FT.Patients with lower education level, lower household income, rural registered residency, and urban and rural residents basic medical insurance were more likely to have higher FT.These were demonstrated in this study and in previous studies. 14,16linical factors related to health care costs are vital indicators to recognize patients' FT. 12,43 In this study, patients with advanced cancer, longer years since diagnosis, and worse self-reported health status may have severe FT, and patients with benign tumors may have a lighter FT.Besides, receiving medical assistance is a risk factor in FT, which is a reverse causation.In clinical practice, government personnel and health care providers evaluate the economic status of patients with cancer, identify high-risk groups to aid.Therefore, patients involved in the medical assistance had a heavier financial burden in this study, which to some extent reflected the rationality and precision of selection of aid objects.

Strengths and limitations
This study has some strengths.This study is a nationwide multicenter survey focusing on SDM as well as FT in cancer clinical practice, and verifying the positive association of SDM on alleviating FT, which adds to crucial evidence for  The Oncologist, 2024, Vol. 29, No. 8 e1039 international fields.Meanwhile, patient characteristics of higher FT and worse SDM were described to facilitate targeted focus and intervention for at-risk groups.Potential coping actions patients may take when facing financial burden indicated targeted points to monitor and administrate for oncologists and health system.Some limitations also existed in this study.First, this is a cross-sectional survey and causality cannot be inferred.This study evaluated one SDM process during one hospitalization.Although it is acceptable and common in the cross-sectional survey, a longitudinal study with repeated-measures will add more strengths.Second, there is no widely accepted tool for measuring the process of SDM. 30,44Our study quantifies SDM using 2 patient-reported items, which takes patient-centered values into consideration and has its strength.At the same time, it is a pity that the types and contents of decision were not examined in our study and their effect was unexplored.The more pinpoint-designed tool and precise measures remain to be conducted in the future.Third, this study has recall bias due to the self-reported data source.The recall bias was somewhat limited because we investigated patients who just near discharge and they had relatively clearer memory about the hospitalization experience.Fourth, detailed treatment schemes information was lacking, thus the effect of treatment schemes on FT was not analyzed.Linking surveyed data with electronic medical records helps to carry out more in-depth exploration in the future.Finally, due to the limitation of time and cost, this study enrolled only public tertiary cancer hospitals, not private and other public hospitals, which weakened the representation of the study population to some extent.This may lead to relatively high SDM and FT levels because these hospitals usually have better service strengths and accommodate patients with severe cancer.

Conclusions
This study conducted in China described the prevalence of SDM, FT and coping actions among adult patients with cancer, and further explored the impact of SDM on FT, as well as identified patient characteristics prone to FT.These findings contribute to potential intervention points at the level of health system, oncologists, and patients.A more supportive environment in future is needed so as to help us find at-risk groups, promote SDM between oncologists and patients with cancer, alleviate the effect of FT, and improve the experience of cancer care and health outcomes for patients with cancer.Besides, more in-depth studies remain to be conducted in the future and take the extent and quality of SDM as well as longterm FT into consideration.

Figure 3 .
Figure 3. Prevalence of coping actions by different SDM groups.

Table 1 .
.52% of patients COST score and FT among Chinese patients with cancer.

Table 1 .
Continued e1036The Oncologist, 2024, Vol.29, No. 8 1Others include commercial insurance and no medical insurance.2 Medical assistance includes national medical aid, drug donation from enterprises, or participation in clinical trials.Abbreviations: UEBMI, Urban Employees Basic Medical Insurance; URBMI, Urban and Rural Residents Basic Medical Insurance.

Table 2 .
Shared decision-making among Chinese patients with cancer.

Table 2 .
Medical assistance includes national medical aid, drug donation from enterprises, or participation in clinical trials.Abbreviations: UEBMI, Urban Employees Basic Medical Insurance; URBMI, Urban and Rural Residents Basic Medical Insurance; SDM, shared decision-making.Continued 2

Table 3 .
Regression of SDM on FT status.

Table 4 .
Regression of SDM on COST score.
Prevalence of coping actions by different FT groups.